CONSULTANCY CALL FOR HPV VACCINE WORKING GROUP

Overview

The Kenya National Immunization Technical Advisory Group (KENITAG) was established by the Ministry of Health in 2014 to provide recommendations on vaccine policy in accordance with the National Health Sector Strategic Plan and the National Policy Guidelines for Immunization, 2013. The group provides technical advice on policy analysis and strategy formulation for all vaccineâpreventable diseases, guides the government on identifying important information for monitoring and evaluation, and provides updates on the latest immunization scientific recommendations and advancements.

Cervical cancer is among the most common cancers in women worldwide, with 570,000 new cases and 311,365 deaths annually. 85% of Cervical Cancer cases are in developing countries. In Kenya, cervical cancer is the second most common cancer and the leading cause of cancer related deaths. Despite being preventable, 5,236 cases of cervical cancer are diagnosed with over 3,268 cervical cancer deaths occurring in Kenya in the year 2020 alone. Without intervention, this number is projected to more than double by the year 2040

The country conducted a HPV demonstration project (2013-2015) to assess coverage, acceptance and affordability/ feasibility. Generally, the vaccine was well accepted, achieving high coverage of 86%. The country received an advisory opinion to introduce HPV vaccine nationwide from the Kenya National Immunization Technical Advisory Group (KENITAG).

The Ministry of Health through the National Vaccines and Immunization Program introduced HPV vaccine in to the routine immunization schedule targeting 10-year-old girl with a dose schedule given six months apart and offered in all public health facilities at no cost

The HPV vaccination coverage remained low during the Covid-19 Pandemic due to the prolonged closure of schools and caregivers were unwilling to take their children to the facility for HPV vaccination for fear of contracting the disease in the hospital. In response to this, and to be able to catch up on girls missed the ministry of health through the national vaccines and immunization program, conducted periodic Intensification of Routine immunization between November to February 2021 and expanded to multi age cohort from 10 years to 10-14 year old girls. Currently the national HPV vaccine coverage is 59% for HPV-1 and 30% for HPV-2. However, there is still a significant sub-national variation in the coverage; for instance, for HPV-1, coverage range from as low as 15% to as high as 95% in some counties and from 3% to as high as 75% for HPV-2 in other counties.

The 2020 WHO Global Strategy to Accelerate the Elimination of Cervical as a Public Health Problem recommends that HPV vaccines should be included in all national immunization programmes and should reach 90% of all girls by age 15 by 2030.

WHO position paper (2022 update) provide normative guidance to Member States on Data from immunogenicity trials, post-hoc analyses of efficacy trials, and post-licensure observational studies among females. The studies demonstrate that, a single dose of HPV vaccine is sufficient to elicit an immune response that provides similar protection as a multidose regimen against initial and persistent HPV infection.

As an off-label option, a single-dose schedule can be used in girls and boys aged 9â20 years. This is in addition likely to increase coverage of the girls vaccinated and result to reduced cervical cancer incidence in future.

In this regard; NVIP presented HPV question to KENITAG

Does KENITAG recommend switch to a single dose vaccination schedule for HPV vaccine based on the current WHO position paper as an off label option?

The program seeks the advice of KENITAG on the following issues:

Justification and Rationale for Vaccine switch from two dose to single doseThis is to build on the information from the clinical studies that informed the recommendation for single dose strategy(-ies) to reach the target population ensuring adequate coverage, high acceptance and sustainabilityRecommend a primary and secondary delivery strategy for selected target population Choice of antigenEfficacy/cost considerations Target population and age groupRoutine cohortPossibility of initial multi-age cohort (catch up)

KENITAG mode of operations anticipates that working groups (WGs) are established to review and provide evidence-based information and options for recommendations that will inform KENITAG deliberations. During its March 2023 statutory meeting, the need for a WG on HPV vaccine was decided and Dr MaryBeth Maritim was designated as the Chair of the WG and Dr Amukoye as the Co-Chair.

The WG held its first meeting held on 20th to 21st April 2023 and the second meeting held on 16th to 19th May 2023. The meetings focused on reviewing and aligning the functionality of the working group and status of the current HPV Vaccination in Kenya. The working group identified subject matter experts and consultant to be co-opted into the group.

The consultant will be required to conduct a search and assess quality of evidence on the justification and rationale for HPV Vaccine switch from two dose to single dose. The consultant will be required to prepare a technical report with proposed recommendations.

Responsibilities

A detailed description of the tasks assigned is provided below.

TASKS ASSIGNED

Component 1: Development of background chapter of technical report

Description: In preparation for the final technical report, the consultant will be required to develop the background chapter preceding the WG findings. This section should include background information on the subject of HPV disease, the prevalence, incidence and mortality and vaccination.

This section should be appropriately referenced using EndNote or the reference manager provided in Microsoft office word.

Time allocated:3 days

Component 2: Summarizing articles

Description: Search and summarize articles on the justification and rationale for introduction of HPV vaccine as guided by the recommendation framework (Annex 1) These articles should be summarized according to the template provided in the procedures manual as follows: (4 tables on page 25)â¦â¦.

Table 1: Search process

Table 2: Search results

Table 3: Search outcome

Table 4: Grading of studies

Time allocated: 5 days

Component 3: Development of the chapter of the technical report on the synthesis of the evidence

Description: In this chapter, for each specific element of the justification and Rational for introduction of the HPV vaccine, the consultant will be required to summarize the findings from all relevant articles into continuous prose, in essence providing a summary of the evidence.

The write up should include data summary tables. It is essential to ensure that the text is appropriately referenced and plagiarism avoided.

Time allocated: 5 days

Component 4: Active participation in face-to-face HPV Vaccine Working Group meetings

Description: A total of 8 face-to-face working group meetings are planned, two 2-day meetings per month in the months of August to November. The consultant will be required to participate in 5 WG meetings out of the 7 planned meetings.

Time allocated: 4 days

Component 5 : Development of draft introduction plan and budget to be used during the Gavi application

Time allocated: 5 days

GENERAL EXPECTATIONS

The following is expected:

Writing will be appropriately referenced. Plagiarism will be avoided. Writing will be clear, coherent and scientific. Information provided to the consultant as a result of working with the KENITAG HPV vaccine WG will be kept confidential. The consultant will be required to sign the KENITAG confidentiality agreement. Any conflict of interest that may be perceived to influence the consultantâs work will be declared to KENITAG. The consultant will be required to sign the KENITAG conflict of interest form. HPV VACCINE WORKING GROUP SUPPORT

To facilitate the tasks in this scope of work:

The HPV Vaccine WG will provide the template for data abstraction. The HPV Vaccine WG will provide access to any other information that may be useful to completion of the assigned tasks TIMELINES AND REPORTING

Once we agree on the number of days to engage the consultant the timelines will be finalized.

Clarification on element specific task assignments can be sought from the chair of the WG. General progress and submission of the finalized chapters/documents by the consultant shall be e-mailed to the WG Chair Dr Marybeth Maritim at the following email address and copy to the following persons:

Evans Amukoye (HPV vaccine WG co-chair): MS Edwina Anyango (WG secretariat focal person): PAYMENT

Payment will be provided as per the terms of this agreement, supported by JHPIEGO. The consultant will submit invoices and activity reports to JHPIEGO through

Rosemary JHPIEGO

Annex 1: Recommendation framework

Issue

Element

Specific data

1. DISEASE

Burden of disease

· Incidence of infection and sub-populations (age, sex, and co-morbidity) with more severe forms of disease under 5 mortality

· Disease occurrence over time

· Epidemic potential

· % of infected becoming carriers and risks facto

· Short- and long-term consequences of infection and frequency

· Social and economic impact of the disease

Use and costs of health care

· Short- and long-term use of health care (incl. treatments and hospitalization)

· School and work absenteeism

Alternative preventive measures

· Alternative preventive measures (e.g, health education, better hygiene, vector control) and their effectiveness, costs, and practicality

· Other existing vaccines against the same disease and their effectiveness, costs, and practicality

2.VACCINE AND IMMUNIZATION CHARACTERISTICS

Vaccine presentation and use

· Vaccine presentation, storage volume and cold chain requirements

· Dosage and route of administration

· Administration schedule and possibility of combination with other vaccines

· Flexibility or alternative vaccination schedules to accommodate the present NIPâs schedule

Vaccine indirect effects

· Herd immunity 

· Impact on strain selection

3.VACCINE INTERVENTION OUTCOME SPECIFIC DATA

Safety

· Type, consequences, and frequency of short- and long-term adverse events following vaccination

· Type and frequency of risk groups or risk factors for adverse events

· Contra-indications for vaccination

· For live attenuated vaccines: risk of reversion to virulence

Efficacy and Effectiveness by population and /or subgroups of population

· Type-specific protection afforded

· Critical determinants of the immune response associated with protection

· Duration of protection

· Waning immunity if any

· Optimal vaccination schedule (dosage, age, and booster) to protect the vaccinated individual?

4.ECONOMIC CONSIDERATIONS

Disease related costs

· Direct and indirect costs to patients and families

· Productivity losses

Vaccine related costs and resource use

· One-time start-up costs to implement the vaccine (i-e cold chain investments)

· Annual incremental recurrent costs to administer the vaccine

· Costs to monitor safety and effectiveness of the vaccine

Net impact of intervention on immunization program as well as health sector

· Reduction in health care costs

· Years Lived with Disability (YLD); Disability- Adjusted Life Years (DALYs) or Quality-adjusted life years (QALY)

· Cost-effectiveness ratio of vaccination program

5.HEALTH POLICY AND PROGRAMMATIC ISSUES

Interaction with other existing intervention and control strategies

· Impacts of program (catch-up) on safety and efficacy of other vaccines and other health care sectors

Feasibility

· Availability of the vaccine and long-term supply

· Accessibility of target population

Affordability and sustainability

· Availability of long-term human, technical and ï¬nancial resources for distribution (including cold chain stability)

· Partnerships

Ability to evaluate

· Availability of information systems to measure coverage and vaccine utilization

· Reliability of surveillance system

Regional and international considerations

· Existing of regional and global recommendations

· Potential of disease for international spread and pandemic potential

6.ACCEPTABILITY AND EQUITY

Acceptability

· Perception of the public and medical community about the disease

Equity

· Universality, accessibility, and gratuity of services for the most vulnerable groups

Required Qualifications

A bachelor's degree in a relevant field such as medical background Epidemiology, Public Health, Bioinformatics, pediatrician, social scientist and Medical Informatics. More than 5yrs in the health reaserch field. Master's or even a Ph.D. in these fields is an added advantage Strong working relationship with KENITAG and MOH Strong programming, management and technical skills. Experience in introduction of new vaccines in Kenya. Experience working with MOH and KENITAG personnel and good knowledge of health systems and programs. Excellent analytical, communication and report writing skills Computer literacy, particularly in the use of MS word, Excel and PowerPoint